Bristol Myers Squibb

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5 approvals or clearances and 1 recall recorded by the FDA for this company and its listed subsidiaries.

Approvals and clearances

• Aug 13ZenbexusDrug approval · New drug application approved. Active ingredient: Iberdomide Hydrochloride
• Mar 20OpdivoDrug approval · New use approved (efficacy supplement). Active ingredient: Nivolumab
• Nov 24Opdivo QvantigDrug approval · New use approved (efficacy supplement). Active ingredient: Nivolumab, Hyaluronidase-Nvhy
• Oct 27Opdivo QvantigDrug approval · New use approved (efficacy supplement). Active ingredient: Nivolumab, Hyaluronidase-Nvhy
• Oct 27Opdivo QvantigDrug approval · New use approved (efficacy supplement). Active ingredient: Nivolumab, Hyaluronidase-Nvhy

Recalls

• Oct 21Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton…Class II · Ongoing · Lack of Assurance of Sterility.

From openFDA: Drugs@FDA (new applications and new uses), device 510(k) and PMA decisions, and FDA enforcement reports. Class I recalls are the most serious, Class III the least. Most recalls are started by the company itself. Labeling and manufacturing changes are not listed.

1 notice filed with state agencies, covering 133 workers in total. Employers must warn the state ahead of a plant closing or mass layoff at a site.

• May 2, 2025133 workers · IllinoisBristol Myers Squibb · 1930 & 1950 Innovation Way, 1900 & 1940 USG Dr., Libertyville · Mass Layoff

Official WARN lists from California, Texas, New York, Florida, Illinois and Washington only; notices filed in other states are not shown. Matched on the employer name as filed, so a notice filed under an unrelated subsidiary name can be missing. Dates are the notice date (Washington: the date the state received it).

124 certified in FY2026 Q3, vs 130 a year earlier. 124 positions in total, median offered wage $155K a year.

Labor condition applications for H-1B workers certified by the Department of Labor, counted by decision date (FY2026 Q3: Apr 1, 2026 to Jun 30, 2026, the latest quarter published). A certified application is a step before a visa petition, not a hire or a visa, and one application can cover several positions. Matched by employer ID number or name.

• Vanguard Capital Management

  Schedule 13G: passive · filed Apr 29, 2026 · 153M shares

  7.49%

• STATE STREET CORPORATION

  Schedule 13G: passive · filed Aug 7, 2026 · 103M shares

  5%

Anyone owning more than 5% must file within days. Structured filings exist since December 2024, so older stakes that were never amended may be missing.

• Oct 2

  Global Benchmark for Efficient Drug Pricing (GLOBE) Model

  Final rule · Centers for Medicare & Medicaid Services

Federal rules, proposed rules and notices that name the company by its legal name, from the Federal Register. Being named is not the same as being the target of a rule.